MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.R.L MANIFOLD 3 PORT RIGHT HAND, ROTATING ADAPTOR ON; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Model Number	31-3225
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported, "leakage during clinical use.".
Additional Manufacturer Narrative
A user facility reported, ""leakage during clinical use." three instances of this issue were reported for this part number.This is report 2 of 3.Deroyal industries requested return of the device, however it has not yet been returned.A supplier corrective action request (scar) was sent to the supplier.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once additional information becomes available.
Additional Manufacturer Narrative
A user facility reported, ""leakage during clinical use." three instances of this issue were reported for this part number.This is report 2 of 3.It was previously reported that a supplier corrective action request (scar) would be sent, however, after further investigation, it was determined to not be a vendor issue, and no scar was sent.Deroyal industries requested return of the device, and it was received on march 31, 2025.Deroyal industries, inc.Reviewed specifications and work orders manifolds related to the samples and no issues were found.Within the reviewed work orders, it was found that each functional test including the torque test, vacuum leak test, and hydrostatic tests all met the respective parameters.The final visual 100% inspection was also reviewed, and the products met all acceptance criteria.An inventory check was also performed on 8 manifolds that were present in inventory and all were within specification.Failure modes and effects analysis (fmea) and corrective and preventive actions related to this issue were reviewed and no issues were found.Samples were received and tested.Each of the samples met all testing requirements and were all within specifications for thread thickness and female thread diameter.A complaint to sales ratio was conducted between january 2023 to april 2025 and found to be (b)(4).Root cause: based on the evaluations and testing performed, the issue could not be reproduced or confirmed on the samples returned.All samples were within all acceptance criteria.Corrective and preventive actions: because the issue could not be confirmed, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: MANIFOLD 3 PORT RIGHT HAND, ROTATING ADAPTOR ON
• Common Device Name: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer (Section G): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 21547635
• Report Number: 3004605321-2025-00002
• Device Sequence Number: 8050643
• Product Code: DTL
• UDI-Device Identifier: 00749756719858
• UDI-Public: 00749756719858
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 31-3225
• Device Lot Number: 60878974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown